PMA P050042S012

Device: ARCHITECT ANTI-HCV
Applicant: Abbott Laboratories, Inc.
PMA number: P050042
Supplement: S012
Product code: MZO
Decision date: 2011-06-01
Classification: Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Generic name: Assay, enzyme linked immunosorbent, hepatitis c virus
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT FLEXTRONICS MANUFACTURING (S) PTE LTD. IN SINGAPORE FOR THE MANUFACTURING OF THE ARCHITECT I2000SR PROCESSING MODULE AND THE ROBOTIC SAMPLE HANDLER.

Current openFDA PMA Record#

Device: ARCHITECT ANTI-HCV
Applicant: Abbott Laboratories, Inc.
PMA number: P050042
Supplement: S012
Product code: MZO
Generic name: Assay, enzyme linked immunosorbent, hepatitis c virus
Decision date: 2011-06-01
Decision code: APPR
Date received: 2011-05-04
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT FLEXTRONICS MANUFACTURING (S) PTE LTD. IN SINGAPORE FOR THE MANUFACTURING OF THE ARCHITECT I2000SR PROCESSING MODULE AND THE ROBOTIC SAMPLE HANDLER.